EffectsOfTranscranialPulseStimulationOnDepression-PilotRCT

NCT05006365 | Completed DMC

• 1 other identifier: HongKongPU_HSEARS20210608002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of transranial pulse stimulation (TPS) on young adults with symptoms of depression in Hong Kong. Methods: This is a single-blind randomized controlled trial design with two-armed repeated measures, and participants will be followed up at a 3-months post-stimulation period. Eligbility: 1) aged 18 or over; 2) able to understand/read Chinese; 3) HAM-D-17 score of ≥ 8; 4) provide written informed consent. Exclusion criteria includes: 1) individuals being prescribed a DSM-5 diagnosis other than major depressive disorder (e.g., bipolar affective disorder or schizophrenia); 2) Alcohol or substance dependence; 3) Concomitant unstable major medical conditions or major neurological conditions such as brain tumour, brain aneurysm; 4) Haemophilia or other blood clotting disorders or thrombosis; 5) Significant communicative impairments; 6) Participants with metal implant in brain or treated area of the head; 7) Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment; 8) Pregnant or breastfeeding women. Recruitment: A total of 30 subjects will be recruited from collaborative NGOs and PolyU and randomly assigned into the Intervention Group (TPS) and the Waitlist Control Group on a 1: 1 ratio. Intervention: All participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time. Outcome measurements include depression, anhedonia, instrumental activities of daily living, cognition and neuroimaging.

Conditions

Major Depressive Disorder

Keywords

efficacy; transcranial pulse stimulation

Outcome Measures

Primary Outcomes (1)

• Depression

  Hamilton Depression Rating Scale 17 (HAM-D-17) is a widely used reliable measurement. Scores range from 0 and 52, with higher scores indicating more severe depression.

  Participants will be measured the changes of HAM-D-17 scores at baseline, immediately after intervention and at 3-months follow-up

Secondary Outcomes (4)

• Anhedonia

  Participants will be measured the changes of SHAPS score at baseline, immediately after intervention and at 3-months follow-up

• Instrumental Activities of Daily Living (IADL)

  Participants will be measured the changes of IADL score at baseline, immediately after intervention and at 3-months follow-up

• Cognition

  Participants will be measured the changes of the MoCA scores at baseline, immediately after intervention and at 3-months follow-up

• Neuroimaging

  Participants will be measured the changes at baseline, immediately after intervention and at 3-months follow-up

Study Arms (2)

Transcranial Pulse Stimulation

EXPERIMENTAL

Investigators will use a single-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. The first arm is the Intervention Group (Transcranial Pulse Stimulation) (TPS group)

Device: Transcranial Pulse Stimulation

Waitlist Control Group

ACTIVE COMPARATOR

Second arm is the waitlist control group.

Device: Transcranial Pulse Stimulation

Interventions

Transcranial Pulse Stimulation DEVICE

A total of 30 participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up at 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on depressive symptoms.

Transcranial Pulse Stimulation; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over
• Able to understand/read Chinese
• A HAM-D-17 score of ≥ 8
• Able to provide written informed consent

You may not qualify if:

• Clinical Diagnosis of Major Depressive Disorder (e.g., bipolar affective disorder or schizophrenia)
• Alcohol or substance dependence
• Concomitant unstable major medical conditions or major neurological conditions such as brain tumor, brain aneurysm
• Hemophilia or other blood clotting disorders or thrombosis
• Significant communicative impairments
• Participants with metal implant in brain or treated area of the head
• Participants who undertook corticosteroid treatment within the last six weeks before first TPS treatment
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing HongKongPolyU

Hong Kong, Hong Kong

Location

Related Publications (8)

• Beisteiner R, Lozano AM. Transcranial Ultrasound Innovations Ready for Broad Clinical Application. Adv Sci (Weinh). 2020 Oct 27;7(23):2002026. doi: 10.1002/advs.202002026. eCollection 2020 Dec.

  PMID: 33304757 BACKGROUND

• Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.

  PMID: 6080235 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):834-40. doi: 10.1016/j.jclinepi.2010.02.005. Epub 2010 Mar 25. No abstract available.

  PMID: 20346629 BACKGROUND

• Patterson B, Boyle MH, Kivlenieks M, Van Ameringen M. The use of waitlists as control conditions in anxiety disorders research. J Psychiatr Res. 2016 Dec;83:112-120. doi: 10.1016/j.jpsychires.2016.08.015. Epub 2016 Aug 21.

  PMID: 27585425 BACKGROUND

• Liu WH, Wang LZ, Zhu YH, Li MH, Chan RC. Clinical utility of the Snaith-Hamilton-Pleasure scale in the Chinese settings. BMC Psychiatry. 2012 Oct 31;12:184. doi: 10.1186/1471-244X-12-184.

  PMID: 23110667 BACKGROUND

• Yeung PY, Wong LLL, Chan CC, Yung CY, Leung LMJ, Tam YY, Tang LN, Li HS, Lau ML. Montreal Cognitive Assessment - Single Cutoff Achieves Screening Purpose. Neuropsychiatr Dis Treat. 2020 Nov 6;16:2681-2687. doi: 10.2147/NDT.S269243. eCollection 2020.

  PMID: 33192067 BACKGROUND

• Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. 2008 Apr;108(4):52-62; quiz 62-3. doi: 10.1097/01.NAJ.0000314810.46029.74.

  PMID: 18367931 BACKGROUND

• Cheung T, Ho YS, Yeung JW, Leung SF, Fong KNK, Fong T, Kranz GS, Beisteiner R, Cheng CPW. Effects of Transcranial Pulse Stimulation (TPS) on Young Adults With Symptom of Depression: A Pilot Randomised Controlled Trial Protocol. Front Neurol. 2022 Mar 25;13:861214. doi: 10.3389/fneur.2022.861214. eCollection 2022.

  PMID: 35401418 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Teris Cheung, PhD

  HongKongPolyU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 16, 2021
• Study Start: August 2, 2021
• Primary Completion: May 31, 2022
• Study Completion: January 28, 2023
• Last Updated: March 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)